PROCESS FOR THE PRODUCTION OF RECOMBINANT PROTEINS IN MAMMALIAN CELLS USING GENE EDITING TECHNOLOGY

Abstract

The production of recombinant proteins in mammalian cells has emerged as a cornerstone of modern biotechnology, enabling the large-scale synthesis of complex therapeutic proteins with post-translational modifications comparable to those in humans. Traditional recombinant protein production relies on transfection-based expression systems that often suffer from low yield, instability, and heterogeneity. The advent of advanced gene editing technologies—particularly CRISPR/Cas9, TALENs, and zinc-finger nucleases—has revolutionized this process by allowing precise genomic modifications, stable gene integration, and controlled expression. This paper presents a comprehensive overview of the optimized process for recombinant protein production in mammalian cells through gene editing techniques. The study outlines key steps including selection of host cell lines (e.g., CHO, HEK293), targeted insertion of expression cassettes, promoter engineering, and enhancement of protein folding and secretion pathways. Emphasis is placed on improving yield, product consistency, and scalability while minimizing off-target effects and genetic instability. Furthermore, the paper explores the integration of gene editing with high-throughput screening, bioinformatics-driven design, and bioprocess optimization to streamline production workflows. Case studies of recombinant monoclonal antibodies and therapeutic enzymes are discussed to illustrate practical applications and challenges. Ethical considerations, regulatory frameworks, and potential biosafety issues associated with genome-edited cell lines are also examined. The findings underscore that gene editing-based strategies represent a transformative approach in biomanufacturing, offering precise, efficient, and sustainable methods for producing high-quality recombinant proteins. This advancement paves the way for next-generation biologics and accelerates the development of personalized therapeutics.